Philadelphia, April 2, 2014 Clinical Therapeutics features a special report in its March issue focusing on the science and policy leading up to the US Food and Drug Administration's (FDA) preliminary steps toward restricting industrially produced trans fatty acids, or trans fat, at the federal level. "Trans fat is a compelling topic for Clinical Therapeutics to examine, because although it directly impacts human health, it also cues up controversy in multiple disciplines, including economics and politics," said John G. Ryan, Dr.PH., Topic Editor for Endocrinology and Diabetes, and guest editor for this multi-disciplinary investigation of trans fat.

Trans fat, derived from the partial hydrogenation of vegetable oils, is present in many processed foods and bakery items. The presence of trans fat in such foods is not always obvious, however, due to a 1999 FDA ruling (which became effective in 2006) that allows manufacturers to list the amount of fat per serving from trans fat as 0% if the actual amount per serving is below 0.5%. Scientific evidence linking various health risks with the consumption of trans fat formed the basis for a more recent ruling by the FDA. In the November 8, 2013 issue of the Federal Register, the FDA announced a preliminary ruling that trans fats are not generally recognized as safe (GRAS) for any use in food. This preliminary ruling, which proclaims partially hydrogenated oils as food additives, triggered a public comment period that ended on March 8, 2014.

Although the evidence linking trans fat with heart disease has mounted for years, the evolving science has at times been equivocal, largely because of two unique sources of trans fat: dietary and ruminant. "While there is an almost unanimous view that trans fatty acid should be phased out to less than 1% of total daily energy consumption, a similar consensus has not been reached with respect to TFA from ruminant meats and dairy since the amounts likely to be consumed are modest and outweighed by nutritional benefit," said Paul Nestel, M.D., professor of medicine and senior faculty at Baker IDI Heart and Diabetes Institute in Victoria, Australia, when asked about that evidence. Without federal action, local and state governments have stepped in to regulate trans fat. However, with the completion of the public comment period on March 8, the FDA will now review the evidence that dietary trans fat adversely impacts human health, resulting in a ruling about whether to restrict partially hydrogenated oils (PHOs) from the American diet, and by how much.

Federal regulation for protecting the public's health will likely have an impact on one or more stakeholders, such as the processed food and restaurant industries. The extent to which the impact of federal regulation will be costly, neutral or positive has yet to be determined. Joshua T. Cohen, Ph.D., deputy director of the Center for the Evaluation of Value and Risk in Health and a research associate professor of medicine at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, Boston, asserts that the benefit at the individual level is clearly positive. Dr. Cohen suggested recently that "a comparison of FDA's proposed regulation with other risks and with other measures to improve health reveals that it confers substantial individual benefits at a relatively low cost."

"Trans Fat, Regulation, Legislation and Human Health" includes papers by Dr. Nestel, Dr. Cohen, R. Rammy Assaf and Rishi Sood, MPH. Dr. Nestel describes the cumulative evidence linking TFA and cardiovascular disease while Dr. Cohen measures regulatory action by the FDA from a policy perspective. Mr. Assaf, a recent intern at the World Health Organization Health Systems and Services in Geneva, Switzerland, and a student at the University of Miami Miller School of Medicine, provides context for FDA action by describing the history of TFA regulations. Finally, Mr. Sood, health policy analyst, Bureau of Primary Care Access and Planning, New York City Department of Health and Mental Hygiene, describes the outcome of a voluntary TFA ban in Nassau County, NY. Dr. Ryan, Associate Professor and Director, Division of Primary Care/Health Services Research and Development in the Department of Family Medicine and Community Health at the University of Miami Miller School of Medicine, and Clinical Therapeutic Topic Editor for Endocrinology, Diabetes and Other Endocrine Disorders, summarizes the trans fatty acid debate in his editorial, "No Longer Generally Recognized As Safe ('GRAS')".

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